Abstract
Introduction
The success of total knee arthroplasty (TKA) necessitates precise osteotomies and soft tissue balancing to realign the lower extremity to a neutral mechanical axis. While technological advances have facilitated precise osteotomies, soft tissue balancing has traditionally relied mostly on surgeons’ subjective and variable tactile feedback. As soft tissue imbalance accounts for 35% of early TKA revisions in North America, we aimed to compare outcomes when TKA was balanced free-hand versus a sensor-guided balancing device (VERASENSE, OrthoSensor, Inc (Dania, FL)).
Methods
In a randomized-controlled fashion, patients underwent primary TKA soft tissue balancing either free-hand or with VERASENSE (Orthosensor Inc, Dania FL) at our institution beginning January 2018. With VERASENSE, soft-tissue balancing is considered when the pressure difference between the medial and lateral knee compartments was less than 15 pounds. Data regarding patient-reported outcomes, knee range of motion (ROM), pain level, opioid consumption, inpatient ambulation distance, length of stay (LOS), and incidence of arthrofibrosis was collected and analyzed in a two-year minimum follow-up and target patient goal of 120 patients.
Results
The study cohort thus far consists of 53 patients, average age 72.4 ± 8.8 years. Soft-tissue balance was conducted freehand in 23 patients and the VERASENSE was used in 30 patients. In the free-hand cohort, preoperative patient-reported outcomes for SF-12 Physical, Mental, WOMAC (pain, stiffness, function) parameters, and knee society function score (KSFS) were 39.3, 45.8, 47.7, 37.5, 48.1, and 50.0, respectively and post-operative at 3 months were 45.0, 53.0, 79.5, 72.5, 81.0, and 72.5, respectively; difference between preoperative and post-operative ROM was +8.4 degrees; average VAS pain score in the first 3 post-operative days was 2.9 ± 2.3; average opioid consumption was 100.7 ± 103.3 mg morphine equivalents; average inpatient ambulation per day was 267.9 ± 187.4 feet; average LOS was 2.3 days. In the VERASENSE cohort, patient reported outcomes for SF-12 Physical, Mental, WOMAC (pain, stiffness, function) parameters, and knee society function score (KSFS) were 38.2, 48.6, 40.1, 30.3, 40.0, and 48.7, respectively and post-operative at 3 months were 41.9, 47.6, 67.2, 59.7, 69.1, and 56.7; difference between preoperative and post-operative ROM was +3.9 degrees; average VAS pain score in the first 3 post-operative days was 2.9 ± 2.3; average opioid consumption was 105.8 ± 86.7 mg morphine equivalents; average inpatient ambulation was 384.6 ± 316.1 feet; average LOS was 2.1 days. There was no incidence of arthrofibrosis and subsequent manipulation under anesthesia in the trial.
Conclusion
Short-term follow up of this randomized-controlled trial demonstrates equivalent patient-reported and clinical outcomes when soft-tissue balancing in TKA is performed free-hand versus utilization of VERASENSE, though we hypothesize a difference in the long-term.
